Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)

NCT06482489 | Recruiting DMC

• 1 other identifier: 2024-D0049
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the effectiveness of low-field MRI (0.55T) with high-field MRI (3T) in prostate cancer screening and image quality. It consists of three phases: optimizing the low-field MRI protocol with healthy volunteers, evaluating image quality in patients with metallic artifacts (like hip prostheses), and assessing low-field MRI in patients with suspicious prostate lesions found on high-field MRI.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of as the reference standard.

  Assess the overall quality of prostate MR images obtained with 0.55T compared to 3T MRI in patients with suspected prostate cancer, using metrics of SNR, CNR and the PI-QUAL scaling score. Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of a targeted prostate biopsy as the reference.

  9 months

Secondary Outcomes (2)

• Protocol optimization on healthy volunteers

  1 month

• Image quality on patients with metal implants

  9 months

Study Arms (3)

Healthy volunteers for protocol optimization

The commencement of the study involves the formulation of the 0.55T MRI protocol. For this purpose, a cohort of 23 male volunteers will undergo a 0.55T MRI. The objective is to achieve the same spatial resolution and coverage as observed at 3T.

Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Study of 0.55T Prostate MRI in Adult Men with Metal Implants.

The second phase of the research will be carried out to compare the MRI image quality between 0.55T and 3T MRI. The study will involve 20 adult men, who on 3T prostate MRI, have DWI reported as sub-diagnostic (PI-QUAL \< 3) due to the presence of metallic implant(s).

Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.

The third phase includes 31 patients whose 3T MRIs detected lesions classified as PI-RADS 4/5 and who are scheduled for targeted prostate biopsy.

Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Interventions

Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany). DEVICE

Performing low-field MRI to evaluate image quality with patients carrying metallic implants and assess the detection of suspicious prostate lesions.

Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.; Healthy volunteers for protocol optimization; Study of 0.55T Prostate MRI in Adult Men with Metal Implants.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators initiate the study by establishing a specialized Low-Field MRI protocol. 23 healthy volunteers participate in this phase undergoing a 0.55T MRI to refine imaging sequences for prostate cancer screening. The objective is to optimize these sequences ensuring diagnostic quality on par with the standard 3T MRI, comparing technical settings such as SNR and CNR from healthy volunteers and the retrospective 3T prostate MRI cohort. In WP2, 0.55T MRI exam will be performed on 20 patients who had a previous 3T MRI with a sub-diagnostic prostate MRI, using metrics of SNR, CNR, DWI and the PI-QUAL scaling score due to metallic implants. In WP3, 31 eligible and enrolled patients who have a PI-RADS 4 or 5 lesion detected during a clinical 3T MRI exam with scheduled targeted prostate biopsy will undergo an additional MRI exam at 0.55T (before the biopsy).

You may qualify if:

• Work Package1 (WP): 0.55T MRI Protocol Development
• Healthy male volunteers aged 18 and above.
• Agree to be contacted for incidental findings
• Signed informed consent
• WP2: 0.55T Prostate MRI with patients with metallic implant(s)
• Adult men (≥18 y.o) with 3T MRI reported as sub-diagnostic due to metallic implants
• Signed informed Consent
• WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
• Adult men (≥18 y.o)
• PI-RADS 4/5 lesions detected on 3T MRI, schedules for targeted biopsy
• Signed informed consent

You may not qualify if:

• WP1: 0.55T MRI Protocol Development
• Individuals with a history of prostate cancer
• MR Contraindications as listed in the MR Safety Screening form
• WP2: 0.55T Prostate MRI with patients with metallic implant(s)
• Contraindications as per MD instructions
• Any condition making the patient unsuitable for the study
• Refusal to be notified in case of incidental finding on the examination
• WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)
• Individuals with a history of prostate cancer.
• Contraindications as per MD instructions
• Any condition making the patient unsuitable for the study
• Refusal to be notified in case of incidental finding on the examination

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (6)

• Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.

  PMID: 33172724 BACKGROUND

• Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10.

  PMID: 22322308 BACKGROUND

• Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.

  PMID: 30898406 BACKGROUND

• Karanasios E, Caglic I, Zawaideh JP, Barrett T. Prostate MRI quality: clinical impact of the PI-QUAL score in prostate cancer diagnostic work-up. Br J Radiol. 2022 May 1;95(1133):20211372. doi: 10.1259/bjr.20211372. Epub 2022 Feb 18.

  PMID: 35179971 BACKGROUND

• Giganti F, Allen C, Emberton M, Moore CM, Kasivisvanathan V; PRECISION study group. Prostate Imaging Quality (PI-QUAL): A New Quality Control Scoring System for Multiparametric Magnetic Resonance Imaging of the Prostate from the PRECISION trial. Eur Urol Oncol. 2020 Oct;3(5):615-619. doi: 10.1016/j.euo.2020.06.007. Epub 2020 Jul 6.

  PMID: 32646850 BACKGROUND

• Eldred-Evans D, Burak P, Connor MJ, Day E, Evans M, Fiorentino F, Gammon M, Hosking-Jervis F, Klimowska-Nassar N, McGuire W, Padhani AR, Prevost AT, Price D, Sokhi H, Tam H, Winkler M, Ahmed HU. Population-Based Prostate Cancer Screening With Magnetic Resonance Imaging or Ultrasonography: The IP1-PROSTAGRAM Study. JAMA Oncol. 2021 Mar 1;7(3):395-402. doi: 10.1001/jamaoncol.2020.7456.

  PMID: 33570542 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ileana Jelescu, Prof

  University of Lausanne Hospitals

  STUDY CHAIR

Central Study Contacts

Naïk Vietti-Violi, Dre

CONTACT

0795560240; Naik-Vietti-Violi@chuv.ch

Gorun Ilanjian, Dr

CONTACT

0795560232; Gorun.Ilanjian@chuv.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal-Investigator, Executive Physician of Diagnostic And Interventional Radiology Department

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: November 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CH (1)